NCT05772455招募中1 期
A Phase I, Open-label, Dose-escalation Study of the Safety, Pharmacokinetics and Efficacy of the XZB-0004 in Patients With Solid Tumours
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) (for Part 1a)
研究概览
简要总结
XZB-0004 is a novel and potent small molecule inhibitor of receptor tyrosine kinase AXL.
This is an open-label, multicentre phase I study of XZB-0004 in patients with solid tumors. Part 1 is a dose-escalation study to evaluate the safety, pharmacokinetic (PK), and pharmacodynamic profile of XZB-0004, and then to identify a safe and pharmacologically active dose for evaluation in subsequent cohorts or clinical studies. Part 2 is a study to evaluate the efficacy and safety of XZB-0004 combined with Penpulimab in patients with NSCLC or advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has signed informed consent before any trial related activities.
- •Be 18 years of age or older and less than 75 years at the time of signing the informed consent.
- •Part 1: Have a histologically or cytologically confirmed diagnosis of a solid tumour malignancy; Part 2：Have a histologically or cytologically confirmed diagnosis of a NSCLC or solid tumour malignancy.
- •Have evaluable (for Part 1) or measurable (for Part 2) disease as the Response Evaluation Criteria in Solid Tumours (RECIST) 1.
- •Have a performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- •Have adequate organ function.
- •Have recovered to ≤ grade 1 or Meet the requirements of the study from the effects of any prior cancer therapy, except for alopecia; irreversible neuropathy should have recovered to ≤ grade
- •Have a life expectancy greater than 3 months.
- •Eligible patients (male and female) who are fertile must agree to at least use a reliable contraceptive method with partner.
- •Willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
排除标准
- •Previous use of AXL inhibitors and immunotherapy was consistent with protocol requirements.
- •Received anti-tumor therapy such as chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy or other therapy within 4 weeks prior to the first dose of the investigational drug.
- •Received other unmarketed investigational drugs or treatments within 4 weeks or 5 times the elimination half-life prior to the first dose of the investigational drug.
- •Treatment with systemic glucocorticoids (prednisone > 10mg per day or equivalent) or other immunosuppressive agents within 14 days before the first dose of a trial drug.
- •Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug.
- •Patient with heart function impaired or clinically significant heart disease.
- •Any condition or illness that, in the opinion of the Investigator, would interfere with the evaluation of the safety of the study drug.
- •History of immune deficiencies, including positive HIV antibody tests.
- •Patient is in the active stage of HBV or HCV.
- •History of solid organ transplant or bone marrow transplant.
- •Any other malignant tumor has been diagnosed within 5 years.
- •Has known Primary tumor of the central nervous system or central nervous system metastase.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage were present within 4 weeks before the first dose of the trial drug.
- •Subjects with psychiatric disorders that may affect trial compliance.
- •history of Alcoholism or drug abuse.
- •Pregnant or breastfeeding.
- •The researchers considered that there were some cases that were not suitable for inclusion.
研究组 & 干预措施
XZB-0004
Experimental
干预措施: XZB-0004 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) (for Part 1a)
时间窗: Up to 3 weeks
Determine MTD of XZB-0004
Recommended phase 2 dose (RP2D）(for Part 1a)
时间窗: Up to 3 weeks
Determine RP2D of XZB-0004
Overall Response Rate (ORR) (for Part 1b)
时间窗: Up to 2-3 years
Number of participants who achieved a best response of either complete response (CR) or partial response (PR) during treatment evaluated by investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
次要结局
- Pharmakinetic parameter - AUC0-t (for Part 1a and Part 1b)(Up to 63 days)
- Overall Response Rate (ORR) (for Part 1a)(Up to 2-3 years)
- Pharmakinetic parameter - Tmax (for Part 1a and Part 1b)(Up to 63 days)
- Pharmakinetic parameter - t½ (for Part 1a and Part 1b)(Up to 63 days)
- Pharmakinetic parameter - CL/F (for Part 1a and Part 1b)(Up to 63 days)
- Pharmakinetic parameter - Vz/F (for Part 1a and Part 1b)(Up to 63 days)
- Overall survival (OS) (for Part 1a and Part 1b)(Up to 2-3 years)
- Pharmakinetic parameter - Cmax (for Part 1a and Part 1b)(Up to 63 days)
- Duration of response (DOR) (for Part 1a and Part 1b)(Up to 2-3 years)
- Pharmakinetic parameter - AUC0-∞ (for Part 1a and Part 1b)(Up to 63 days)
- Progression free survival (PFS) (for Part 1a and Part 1b)(Up to 2-3 years)
- Disease control rate (DCR) (for Part 1a and Part 1b)(Up to 2-3 years)
- Incidence and severity of adverse events (AEs)(for Part 1b)(Up to 2-3 years)
研究者
研究点 (1)
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